PART CDrugs (continued)
DIVISION 1 (continued)
Shortages of Drugs and Interruption and Discontinuation of Sale of Drugs (continued)
C.01.014.11 The Minister shall ensure that a hyperlink to the website referred to in subsection C.01.014.9(1) is on the Government of Canada website.
- SOR/2016-139, s. 5;
- SOR/2017-259, s. 11.
C.01.014.12 [Repealed, SOR/2017-259, s. 11]
C.01.014.13 [Repealed, SOR/2017-259, s. 11]
Tablet Disintegration Times
C.01.015 (1) Subject to subsection (2), no person shall sell for human use a drug in the form of a tablet that is intended to be swallowed whole unless, when tested by the official method DO-25, Determination of the Disintegration Time of Tablets, dated July 5, 1989,
(a) in the case of an uncoated tablet, the tablet disintegrates in not more than 45 minutes;
(b) in the case of a plain coated tablet, the tablet disintegrates in not more than 60 minutes; and
(c) in the case where the label of the drug indicates that the tablet carries an enteric coating or a coating designed to serve a purpose similar to that of an enteric coating, the tablet does not disintegrate when exposed for 60 minutes to simulated gastric fluid, but when it is subsequently exposed for a continuous period to simulated intestinal fluid, the tablet disintegrates in not more than 60 minutes.
(2) Subsection (1) does not apply in respect of a drug in the form of a tablet where
(a) a notice of compliance in respect of the drug in the form of a tablet has been issued under section C.08.004 or C.08.004.01;
(b) [Repealed, SOR/98-423, s. 7]
(c) a dissolution or disintegration test for the drug in the form of a tablet is prescribed in Division 6 of this Part;
(d) the drug is labelled as complying with a standard contained in a publication referred to in Schedule B to the Act;
(e) the drug has been demonstrated by an acceptable method to be available to the body; or
(f) representations regarding the drug are made on its label, or in any advertisement, with respect to the site, rate or extent of release to the body of a medicinal ingredient of that drug, or the availability to the body of a medicinal ingredient of that drug.
- SOR/89-429, s. 2;
- SOR/89-455, s. 3;
- SOR/94-36, s. 2;
- SOR/98-423, s. 7;
- SOR/2011-88, s. 4.
C.01.016 No manufacturer shall sell a drug unless the manufacturer complies with the conditions set out in sections C.01.017 to C.01.019.
- SOR/95-521, s. 2;
- SOR/2011-31, s. 1.
Serious Adverse Drug Reaction Reporting
C.01.017 The manufacturer shall submit to the Minister a report of all information relating to the following serious adverse drug reactions within 15 days after receiving or becoming aware of the information, whichever occurs first:
(a) any serious adverse drug reaction that has occurred in Canada with respect to the drug; and
(b) any serious unexpected adverse drug reaction that has occurred outside Canada with respect to the drug.
- SOR/95-521, s. 2;
- SOR/2011-31, s. 1.
Annual Summary Report and Case Reports
C.01.018 (1) The manufacturer shall prepare an annual summary report of all information relating to adverse drug reactions and serious adverse drug reactions to the drug that it received or became aware of during the previous 12 months.
(2) The annual summary report shall contain a concise, critical analysis of the adverse drug reactions and serious adverse drug reactions to the drug.
(3) In preparing the annual summary report, the manufacturer shall determine, on the basis of the analysis referred to in subsection (2), whether there has been a significant change in what is known about the risks and benefits of the drug during the period covered by the report and shall include its conclusions in this regard in the summary report.
(4) If, in preparing the annual summary report, the manufacturer concludes that there has been a significant change, it shall notify the Minister without delay, in writing, unless this has already been done.
(5) The Minister may, for the purposes of assessing the safety and effectiveness of the drug, request in writing that the manufacturer submit to the Minister one or both of the following:
(6) The Minister shall, after giving the manufacturer an opportunity to be heard, specify a period for the submission of the annual summary reports or case reports, or both, that is reasonable in the circumstances, and the manufacturer shall submit the reports within that period.
- SOR/2011-31, s. 1.
C.01.018.1 Section C.01.018 does not apply in respect of a veterinary health product.
- SOR/2017-76, s. 4.
Issue-Related Summary Report
(2) The report shall contain a concise, critical analysis of the adverse drug reactions and serious adverse drug reactions to the drug, as well as case reports of all or specified adverse drug reactions and serious adverse drug reactions to the drug that are known to the manufacturer in respect of the issue that the Minister directs the manufacturer to analyze in the report.
(3) The Minister shall, after giving the manufacturer an opportunity to be heard, specify a period for the submission of the report that is reasonable in the circumstances. The Minister may only specify a period that is less than 30 days if the Minister needs the information in the report to determine whether the drug poses a serious and imminent risk to human health.
(4) The manufacturer shall submit the report within the specified period.
- SOR/2011-31, s. 1;
- SOR/2017-18, s. 14.
C.01.019.1 Section C.01.019 does not apply in respect of a veterinary health product.
- SOR/2017-76, s. 5.
Maintenance of Records
(2) The manufacturer shall retain the records for 25 years after the day on which they were created.
- SOR/2011-31, s. 1.
Limits of Drug Dosage
C.01.021 Except as provided in these Regulations, no person shall sell a drug for human use listed in the following table unless both the inner and the outer labels other than the inner label of a single dose container carry a statement of
(a) the quantitative content of the drug,
(b) the recommended single and daily adult dose designated as such, except for
(c) adequate directions for use when the drug is recommended for children which shall be either
(i) the statement “CHILDREN: As directed by the physician”, or
(ii) a suitable reduced maximum single and daily dose which shall not exceed the following:
Age in years Proportion of adult dose 10 - 14 one-half 5 - 9 one-fourth 2 - 4 one-sixth under 2 years as directed by physician
Table of Limits of Drug Dosage for Adults
Item External Use Internal Use — — Maximum Limit Maximum Dosage Unless otherwise stated, doses are in milligrams Per cent Single Daily Acetaminophen — 650 4.0 g Acetanilide and derivatives (except N-Acetyl-ρ-amino phenol) — 65 195 Acetylsalicylic Acid — 650 4.0 g Aconitine, its preparations and derivatives 0.2 0.1 0.1 Adonis vernalis — 65 195 Amylocaine, its salts and derivatives when sold or recommended for opthalmic use 0.0 0.0 0.0 Amylocaine Hydrochloride, except when sold or recommended for ophthalmic use 1.0 0.0 0.0 Antimony, compounds of — 3.3 13 Atropine, Methylatropine, and their salts 1.0 0.13 0.44 Belladonna and its preparations, on the basis of belladonna alkaloids 0.375 0.13 0.44 Benzene (Benzol) — — — Benzocaine 8.0 195 585 Beta-Naphthol — 195 585 Butacaine, its salts and derivatives when sold or recommended for ophthalmic use 0.0 0.0 0.0 Butacaine Sulphate, except when sold or recommended for opthalmic use 1.0 0.0 0.0 Cadexomer Iodine 0.0 0.0 0.0 Cantharides, cantharidin, and their preparations, on the basis of cantharidin, except blisters 0.03 0.0 0.0 Cantharides, blisters only 0.2 0.0 0.0 Cedar Oil 25.0 0.0 0.0 Chlorbutol (not more often than every 4 hours) — 325 975 Choline Salicylate — 870 5.22 g Cinchocaine Hydrochloride, except suppositories 1.0 0.0 0.0 Cinchocaine Hydrochloride, suppositories only — 11 11 Colchicine and its salts — 0.55 1.65 Colchicum and its preparations, on the basis of colchicine — 0.27 0.81 Croton Oil 10.0 0.0 0.0 Cyproheptadine and its salts—when sold or recommended for the promotion of weight gain — 0.0 0.0 Ephedrine and its salts — 11 32.5 Ephedrine and its salts, sprays 1.0 — — Epinephrine and its salts, sprays 1.0 — — Gelseminine (Gelsemine) and its salts (not to be repeated within 4 hours) — 0.55 1.65 Gelsemium and its preparations, on the basis of the crude drug — 16.2 48.6 Hydrocyanic (Prussic) Acid as 2 per cent solution — 0.062 ml 0.31 ml Hydroquinone 2.0 — — Hyoscine (Scopolamine) and its salts 0.5 0.325 0.975 Hyoscine aminoxide hydrobromide 0.5 0.325 0.975 Hyoscyamine and its salts — 0.325 0.975 Hyoscyamus and its preparations, on the basis of hyoscyamus alkaloids — 0.073 0.22 Lobelia and its preparations, on the basis of the crude drug — 130 390 Lobeline and its salts — 2.0 6.0 Magnesium Salicylate — 650 4.0 g Methyl Salicylate 30 — — Methylene Blue — 130 390 Phenacetin — 650 1.95 g Phenazone and compounds thereof — 325 975 Phenol 2.0 32.5 260 Phenylpropanolamine when sold or recommended as an appetite depressent — 0.0 0.0 Phosphorus — 0.0 0.0 Podophyllin 0.0 0.0 0.0 Potassium Chlorate — 325 975 Potassium Chlorate, gargle 2.5 — — Procaine and its salts — — — Proxymetacaine, its salts and derivatives when sold or recommended for ophthalmic use 0.0 0.0 0.0 Salicylamide — 975 2.925 g Santonin — 65 130 Selenium and its compounds 2.5 0.0 0.0 Sodium Chlorate — 325 975 Sodium Fluoride — 0.1 0.1 Sodium Salicylate — 650 4.0 g Squill and its preparations, on the basis of crude drug — 32.5 97.5 Stramonium and its preparations, on the basis of stramonium alkaloids — 0.16 0.65 Strychnine and its salts — 0.0 0.0 Tannic Acid — 150 1 000 Tetracaine, its salts and derivatives when sold or recommended for ophthalmic use 0.0 0.0 0.0 Thiocyanates 0.0 0.0 0.0 Urethane 0.0 0.0 0.0
Where drugs having similar physiological actions occur in combination, the dosage of each shall be proportionately reduced.
Accurate dosagesmay be expressed in either metric units or imperial units. If the dosage is expressed in both systems, then an approximation may be used for one expression, but such approximation must precede or follow the accurate statement by which the product will be judged and must be in brackets.
- SOR/78-422, s. 1;
- SOR/80-544, s. 3;
- SOR/84-145, s. 1;
- SOR/85-715, s. 3;
- SOR/85-966, s. 2;
- SOR/88-94, s. 1;
- SOR/89-229, s. 2;
- SOR/89-548, s. 1.
- Date modified: